The U.S. Food and Drug Administration (FDA) recently released its “Blueprint for the Future” (Blueprint) as part of the New Era of Smarter Food Safety initiative. Launched in April 2019, this effort seeks to build upon FDA’s work implementing the FDA Food Safety Modernization Act (FSMA) by establishing a new approach to food safety that leverages technology and other tools to create a safer and more traceable food system. The Blueprint “envision[s] a framework that will enable food to be traced to its source in seconds and will utilize new data analytical techniques to strengthen prevention of foodborne illnesses, alerting consumers in real time before contaminated or misbranded foods are consumed.” In many respects, the Blueprint is a strategic plan that will guide FDA’s food safety priorities in the coming years. As such, there are no specific timelines or action steps set out in the document.

FDA was poised to release the Blueprint in March 2020, but was delayed when the agency pivoted to focus its efforts on its response to the COVID-19 pandemic. In his comments announcing the release of the Blueprint, Dr. Stephen M. Hahn, the Commissioner of Food and Drugs, explained how events and trends that arose following the outbreak of COVID-19, such as supply-chain imbalances and increased reliance on food delivery services, have underscored the importance of the initiative.

The Blueprint outlines goals for FDA over the next decade to enhance traceability, improve predictive analytics, respond more rapidly to outbreaks, address new business models, reduce contamination of food, and foster the development of a food safety culture. It is organized around the four core elements, explained below, which the agency initially identified in the “Food for Thought” outline of ideas the agency released in October 2019. FDA also has identified the senior leaders who will lead FDA’s efforts in achieving the goals in each of the four core elements.

This post highlights some of the goals within in each of the four core elements. More details are provided in the Blueprint itself. Click here to read more. 

The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug Administration (FDA) and the United States Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS), Animal Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), and Agricultural Marketing Service (AMS).

After highlighting the most significant priorities, we provide charts that enumerate other relevant rules included on each agency’s agenda. More information can be found by clicking on the blue “RIN” link, which will direct you to a page on OMB’s website dedicated to each agenda item.

We want to caution that the dates included in the Unified Agenda are not commitments to act on or by the date shown and simply indicate the agencies’ aspirations. Note, for example, that dates for some planned actions have already passed. Rather than focusing on projected dates, the Unified Agenda is a valuable tool to identify the substantive issues the agencies consider to be priorities for rulemaking.

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A recent action by the National Advertising Division (NAD), a self-regulatory arm of the Better Business Bureau, addresses the level of proof necessary to support “natural” and “satiety” claims involving competing experts and a variety of scientific data in dispute. The Proctor & Gamble Company (P&G) successfully challenged three claims made by GlaxoSmithKline Consumer Healthcare, LLC (GSK) for its Benefiber Original and Benefiber Healthy Shape products. GSK disagreed with the case outcome, appealing NAD’s findings and recommendations to the National Advertising Review Board (NARB). Beyond the NAD’s specific findings, the decision also provides useful insight into how NAD evaluates health benefit and related claims and analyzes the corresponding scientific evidence and other substantiation. The outcome of the NARB appeal will likely shed further light on how the claims substantiation issues involved should be addressed by advertisers in the future.

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Dr. Stephen M. Hahn, the Commissioner of Food and Drugs for the Food and Drug Administration (FDA) issued a statement on July 10, 2020, describing the agency’s intentions and approach to resuming domestic inspections in light of the COVID-19 pandemic. After temporarily suspending inspections in March 2020, FDA is working toward restarting on-site inspections during the week of July 20, 2020. However, this timeline will depend on the data about the coronavirus trajectory in a given state and locality, and the rules and guidelines that are in place by state and local governments. FDA also notes that, for the foreseeable future, domestic inspections will continue to be pre-announced to FDA-regulated businesses. Note that this announcement is not limited to the food industry, but the impacts for the food industry are the focus of this post.

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The European wine sector has been greatly affected by the COVID-19 pandemic. According to statistics from the European Commission (EC), there has been a 30% reduction in the volume of wine sold and a 50% drop in the value of sales across the EU from mid-March until to end of May 2020, compared to sales before the closures. As simply put by the EC, while COVID-19 has led to an increase of home consumption in wine, this has not compensated for the drop in demand in the hospitality and catering industry resulting in part from the closure of bars, restaurants and hotels. In recognition of the economic disruption faced by growers and producers of wine, and the fact that the situation is not forecasted to improve in the next 6 months, the EC has taken a rare step to adopt legislation to formally authorise certain agreements in the wine sector that may have otherwise fallen foul of EU competition law.

Article 101(1) of the Treaty on the Functioning of the European Union prohibits agreements that restrict competition. The prohibition includes, for example, agreements between market players that are aimed at limiting or controlling production. Thus, actions between suppliers seeking to agree on production volumes would typically be caught under Article 101(1) TFEU and be void, and potentially attract fines.

Under  Regulation (EC) No 1308/2013 (otherwise known as the Common Markets Organisation Regulation), the EC is allowed to adopt acts that suspend the application of Article 101(1) TFEU to agreements in certain agricultural sectors during periods of “severe imbalance in markets” where the agreements strictly aim at stabilising the sector and do not impair the functioning of the internal market.

The EC has now adopted a new Regulation (2020/975) which specifically authorises farmers, farmers’ associations, associations of such associations, recognised producer organisations, associations of recognised producer organisations and recognised interbranch organisations (“operators”) to enter into agreements on the production of wine grapes and wine, including with regard to transformation and processing, storage, joint promotion, quality requirements and production planning. Provided that these agreements do not impair the functioning of the internal market, and are strictly aimed at stabilising the wine sector, they benefit from derogation from Article 101(1) TFEU. Importantly, the derogation does not apply to agreements on partitioning the market, discrimination on the basis of nationality or price-fixing. The derogation applies for period of 6 months from 8 July 2020, covering the first part of the 2020/2021 wine marketing season which starts in August.

The Regulation will increase the level of scrutiny by competition authorities in the wine sector. Already back in April last year, the French competition authority raided the premises of companies suspected of having engaged in possible anticompetitive practices involving wine and spirits. While there has been no suggestion that that particular investigation is now impacted by the EC’s measures (indeed the derogation does not have retrospective effect), the actions of operators in the wine sector will now be in the spotlight. The price of derogation from the competition rules is a reporting mechanism for operators to report on their concluded agreements, and for Member States in turn to report on those agreements to the EC. Competition authorities throughout the EU will now have to closely monitor cooperation efforts in this sector.

We would like to bring to your attention to three recent developments related to California’s Proposition 65. On July 8, the Office of Environmental Health Hazard Assessment (OEHHA) adopted three safe harbor levels or maximum allowable levels (MADLs) for the chemical chlorpyrifos. On June 22, the United States District Court (Eastern District of California) entered a permanent injunction barring the enforcement against the cancer warning requirements for glyphosate under Proposition 65.  The court reasoned the cancer warning requirements violate Plaintiffs’ First Amendment rights by compelling them to make false and misleading statements. On June 19, OEHHA proposed to establish a naturally-occurring level of lead in candies containing chili and/or tamarind at 0.02 parts per million (ppm). Notably, OEHHA developed an ingredient-based approach to estimate the sum of lead in candies containing chili and tamarind, based on an evaluation of the lead in each ingredient. Written comments to the proposed rule are due by August 18, 2020.

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The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) issued two final guidance documents providing industry stakeholders with instructions on how to implement certain requirements of the National Bioengineered Food Disclosure Standard (NBFDS). The agency’s Guidance to Ensure Acceptable Validation of a Refining Process outlines steps for validating that a refining process makes modified genetic material undetectable in a food. AMS’s Guidance on Testing Methods provides considerations for the selection of a test method to ascertain that a food or ingredient does not contain detectable modified genetic material and therefore does not require a bioengineered food disclosure. AMS issued draft versions of the guidance documents in December 2019 and February 2020, respectively. AMS also issued new Frequently Asked Questions (FAQs) corresponding to each of the guidance documents. This memorandum summarizes the guidance documents and FAQs, but we encourage any entity relying on the use of a validated refining process or testing to establish that a food is not subject to disclosure under the NBFDS to read the documents in their entirety.

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The Federal Trade Commission (FTC) on 22 June 2020 voted to adopt regulations codifying its long-standing Enforcement Policy Statement on U.S. Origin Claims (Policy Statement). The proposed regulations come after the FTC staff held a workshop in September 2019 to discuss “Made in USA” (MUSA) claims and whether there was a need to update the policy or enforcement approach for such claims. While the proposed regulations make no substantive changes to the “all or virtually all” standard articulated in the Policy Statement, they significantly expand enforcement of MUSA claims to include both offline and online MUSA claims and authorize the use of civil penalties, which could lead to more frequent and enhanced enforcement by the FTC. Comments to the proposed rule are due 60 days after publication of the proposed regulations in the Federal Register.

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The government has announced that on 4 July 2020, it will commence the third stage of its plan to ease the ‘lockdown’ restrictions implemented in England due to COVID-19. Following the re-opening of ‘non-essential retail shops’  in stage two, this third stage will involve the re-opening of restaurants, pubs and bars as well as hairdressers, cinemas, museums and outdoor gyms.

Every restaurant, bar and pub must carry out a risk assessment addressing the risks of COVID-19 and proposing sensible measures to control those risks. Whilst the steps that need to be taken will vary depending on the size, location and nature of the business, the government has issued guidance on how to safely re-open bars, pubs and restaurants. We have set out below some of the key issues that venues should consider when planning for their re-opening. The guidance is specific to England, but the principles may also be of use to establishments offering food and beverages in other jurisdictions.

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There are numerous regulatory and practical issues borne out of COVID-19 that are facing the food industry, many of which are increasingly playing out at the state level. As states grapple with so-called “re-opening” of retail establishments, including restaurants and foodservice operators (including retailers offering ready-to-eat foods), some noteworthy trends and insight into requirements and recommendations are emerging, which will be of interest to the food industry as a whole. This update reflects a review of a number of states’ procedures and highlights a few noteworthy trends, as well as unique approaches that may be useful for businesses to consider for purposes of planning their own re-openings or in modifying internal foodservice practices. This update provides a single “snap-shot” in time. References may be or could soon be outdated as regulations and recommendations continue to change.

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